Posology: Adult females (including the elderly): The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
When Faslodex is used in combination with palbociclib, or ribociclib, please also refer to the Summary of Product Characteristics of palbociclib or ribociclib.
Prior to the start of treatment with the combination of Faslodex plus palbociclib, or ribociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Special populations: Paediatric patient: The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established. Currently available data are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, but no recommendation on a posology can be made.
Renal impairment: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min) and, therefore, caution is recommended in these patients (see Precautions).
Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
For detailed instructions for administration, see Instructions for administration and Special precautions for disposal and other handling under Cautions for Usage.